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STernectOmy Repair Efficiency of a Ceramic Implant

STernectOmy Repair Efficiency of a Ceramic Implant

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02683590
Acronym
STOIC
Enrollment
3
Registered
2016-02-17
Start date
2016-03-31
Completion date
2019-08-31
Last updated
2019-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bones, Tumors

Keywords

Sternectomie, Ceramic Implant, Bones Tumors

Brief summary

For the replacement of the sternum, there is no consensus regarding the most appropriate and most effective physiologically material. The use of ceramic implant offers significant operational time saving and biocompatibility coupled with the strength of the material allow us to realize a more natural operation, limiting the risk of infection and rejection. Main objective: to evaluate the efficiency of the replacement of the sternum by a ceramic implant on the respiratory capacity at 3 months post surgery.

Interventions

DEVICECeramic Implant

The replacement of the sternum by a ceramic implant

Sponsors

University Hospital, Limoges
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient major * Having a replacement indicating the sternum (or a part of the sternum) * With an expected life of over one year, estimated by the principal investigator * Written consent of the patient

Exclusion criteria

* People under safeguard justice, * Patient under guardianship, * Patient pregnant or breastfeeding, * Topic attending another search including a period of exclusion still going to run-in * Contraindication to general anesthesia * Of alumina allergy antecedent * Recent infectious disease unsupported * BMI\> 40

Design outcomes

Primary

MeasureTime frameDescription
vital capacity1 daySlow Vital Capacity (liters), forced vital capacity (liters)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026